Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Advanced Solid Tumor
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Feb 2023 → ongoing
- Decision date (initial)
- 2024-09-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515351-37-00
- EudraCT number
- 2019-001604-38
- ClinicalTrials.gov
- NCT05259709
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-02-07 | 2023-02-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Netherlands | Acceptable with conditions 2024-09-17
|
2024-09-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-12 | Netherlands | Acceptable 2025-03-10
|
2025-03-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-09 | Netherlands | Acceptable 2026-04-14
|
2026-05-18 |